Bulk Pharmaceutical API Sources for SYMPAZAN

Bulk Pharmaceutical API Sources for SYMPAZAN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C8414_SIGMA
NovoSeek		2789
ABI Chem		AC1L1EGZ
ChemMol		30109118
ChemMol		49400647
Chembase.cn		233
Alsachim		1612

Bulk Active Pharmaceutical Ingredient (API) Sources for: SYMPAZAN

Last updated: July 28, 2025

Introduction
Sympazan (clobazam) is a benzodiazepine derivative primarily indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric and adult patients. As a critical component in pharmaceutical formulations, the supply chain and sourcing of its active pharmaceutical ingredient (API) are vital for manufacturing, regulatory compliance, and assured drug availability. This article explores the global sources, key manufacturers, quality considerations, and regulatory landscape for bulk clobazam API, focusing on potential sourcing strategies to ensure supply security for Sympazan.

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Overview of Clobazam API and Market Dynamics
Clobazam, chemically designated as 1-phenyl-4-(5-fluoro-2-phenyl-1H-pyrazol-3-yl)benzodiazepine, has seen increased demand driven by the prevalence of Lennox-Gastaut Syndrome and other seizure disorders. The API market for benzodiazepines, historically dominated by a few global players, faces ongoing pressures relating to quality standards, regulatory approval, and manufacturing capacity expansion. Major regions supplying API include North America, Europe, India, and China, with a growing number of producers in Southeast Asia.

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Leading API Manufacturers for Clobazam

1. Indian API Manufacturers
India holds a significant share of the global API manufacturing industry due to its cost advantages and expanding regulatory compliance. Major Indian companies producing clobazam API include:

• Solara Active Pharma Sciences: A prominent player with WHO-GMP-certified facilities, offering high-quality APIs including benzodiazepines. Their capacity for large-scale production combined with rigorous quality controls makes them a viable source for global supply chains.
• Hetero Labs: Known for extensive API portfolios, Hetero maintains GMP-compliant manufacturing plants with global certifications. Their expertise extends to psychotropic APIs, including derivatives such as clobazam.
• Aurobindo Pharma: One of India’s largest API producers, with FDA-approved facilities, many of whom have obtained WHO-GMP certification, making them suitable for export to regulated markets.

2. Chinese API Manufacturers
China remains a pivotal player, supplying APIs at competitive prices, though buyers must exercise stringent quality verification. Chinese API producers for clobazam include:

• North China Pharmaceutical Group Corporation (NCPC): A state-owned enterprise with comprehensive API manufacturing capabilities, including benzodiazepines, adhering to GMP standards for export.
• Zhejiang Hisun Pharmaceutical Co., Ltd.: Engaged in chemical synthesis of APIs, with extensive experience in CNS-active compounds, compliant with international quality standards.
• Guangzhou PGP Pharmaceutical Co., Ltd.: Specializes in benzodiazepine APIs, with certifications supporting exports to regulated markets.

3. European and North American API Suppliers
While less prevalent, some companies in Europe and North America produce clobazam API scale, primarily serving highly regulated markets:

• Atox BioPharma (Europe): Offers high-purity APIs compliant with EMA standards, suitable for formulations requiring stringent quality parameters.
• Sagent Pharmaceuticals (USA): Focuses on APIs and finished products with an emphasis on compliance with FDA standards, though API manufacturing capacities for clobazam may be limited and often sourced via partnerships.

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Quality Considerations and Regulatory Compliance

API sourcing mandates adherence to strict quality controls, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and compliance with pharmacopoeial standards. Suppliers should possess certifications such as:

• FDA approval or authorization for export
• EMA-certified manufacturing
• WHO-GMP certification for international distribution
• Analytical data confirming API potency, purity (>99%), and batch-to-batch consistency

Notably, the complex synthesis of benzodiazepine APIs warrants detailed review of process validation, residual solvent levels, and impurity profiles. Buyers should prioritize suppliers with documented quality audits and reliable supply histories.

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Supply Chain Trends and Risks

The API market for clobazam is influenced by geopolitical factors, regulatory variances, and pandemic-induced supply chain disruptions. Indian and Chinese manufacturers dominate, but increased regulatory scrutiny necessitates rigorous supplier qualification. Supply shortages are possible during geopolitical shifts or regulatory clampdowns; thus, diversification of sourcing, including multiple reputable suppliers, is advisable.

Additionally, the trend toward regional manufacturing regulations emphasizes the need for suppliers compliant with target markets' standards, such as Form 483 clearances, GMP certifications, and thorough documentation.

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Sourcing Strategies for Sympazan Manufacturing

• Supplier Qualification: Conduct comprehensive audits, review regulatory certifications, and request detailed analytical and process validation data.
• Diversification: Maintain relationships with multiple qualified suppliers across different regions to mitigate supply chain risks.
• Long-term Agreements: Establish contracts with quality-assured vendors to secure price stability and priority supply.
• Quality Assurance: Implement robust incoming inspection procedures, including HPLC potency testing, impurity profiling, and residual solvent assessment.

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Conclusion
The global API landscape for clobazam reflects a complex network of manufacturers with varying compliance standards and capacities. Indian and Chinese suppliers dominate due to cost efficiency and production volumes, but European and North American firms offer high-quality APIs aligned with stringent regulatory markets. Sourcing for Sympazan’s API should prioritize robust quality compliance, supply reliability, and regulatory alignment to maintain continuous drug availability and meet regulatory standards.

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Key Takeaways

• India and China are primary sources for bulk clobazam API, offering scale and cost advantages; European and North American suppliers provide higher compliance assurance.
• Rigorous supplier qualification, including GMP certification and regulatory history, is critical in API sourcing decisions.
• Diversification reduces supply chain vulnerability amid geopolitical and regulatory uncertainties.
• Prioritize suppliers with proven documentation of process validation, purity standards, and batch consistency.
• Strategic planning with long-term agreements and quality audits enhances supply security for Sympazan manufacturing.

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FAQs

1. What are the critical quality parameters for sourcing clobazam API?
API must meet pharmacopoeial standards (e.g., USP, EP), with purity >99%, acceptable residual solvents, and confirmed absence of impurities. Batch-to-batch consistency and validated synthesis processes are essential.

2. Which regions dominate global clobazam API manufacturing?
India and China lead production due to lower manufacturing costs and capacity. Europe and North America supply high-quality APIs aligned with strict regulatory requirements but at higher costs.

3. How can buyers ensure the quality of APIs from emerging suppliers?
Through on-site audits, supplier qualification programs, review of compliance certifications (GMP, WHO-GMP), analytical testing, and validation records before large-scale procurement.

4. Are there any upcoming regulatory changes affecting API sourcing?
Regulatory agencies are increasing scrutiny and enforcement on API manufacturing, especially in China and India. Buyers should stay updated on guidelines from EMA, FDA, and WHO to ensure compliance.

5. What are the risks associated with over-reliance on a single API source?
Supply disruptions, regulatory actions, or quality issues can significantly impact drug manufacturing. Diversification and proactive supplier management mitigate this risk.

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References

[1] U.S. Pharmacopeia. "Clobazam Monograph," USP.
[2] European Pharmacopoeia. "Clobazam Specifications," Ph. Eur.
[3] Market for benzodiazepine APIs: Global Industry Analysts.
[4] WHO Prequalification Reports and GMP Certificates.
[5] Industry insights: API suppliers and trends, PharmaTech Industry Reports.